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NRX-101 Expanded Access

NCT05779267 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2023-03-24

No results posted yet for this study

Summary

There is no currently-approved pharmacotherapy for patients with Treatment-Resistant Bipolar Depression and Suicidal Ideation or behavior. The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have depression and suicidal ideation despite treatment with currently approved medication and to gather information on safety and efficacy in a real-world data environment. Participants will be treated by their own practicing psychiatrist and will agree to periodic psychometric evaluations to assess depression, suicidal ideation, and side effects.

Conditions

Interventions

DRUG

NRX-101

D-cycloserine/lurasidone fixed dose combination

Sponsors & Collaborators

  • Prevail Infoworks

    collaborator INDUSTRY

  • NeuroRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan C Javitt, MD, MPH · NRx Pharmaceuticals

  • Martin Brecher, MD · NRx Pharmaceuticals

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779267 on ClinicalTrials.gov